Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI

• Status: Completed
• Trial end date: 2019-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is to observe the efficacy and safety of glucocorticosteroid treatment in the patients with chronic recurrent drug-induced liver injury (DILI).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing 302 Hospital
• Treatments: Alprostadil; Glycyrrhizic Acid; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

1. Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;

2. Meet any of the following conditions:

• serum AST or ALT ≥ 10 fold ULN;

• serum AST or ALT ≥ 5 fold ULN and TBIL ≥ 2 fold ULN;

• liver histology indicates bridging necrosis or multiacinar necrosis or moderate or more inflammation or inflammation G3 or more;

3. Women of childbearing age had a negative urine pregnancy test, and the subjects are willing to have no family planning during the study and to take effective measures;

4. Voluntary participation, understanding and signing of informed consent, comply with the requirements of the research;

Exclusion Criteria:

1. Patients with serious pre-existent comorbid conditions (vertebral compression fractures,psychosis,active peptic ulcer, brittle diabetes,uncontrolled hypertension;

2. Patients with intolerances to prednisone;

3. Patients with severe infection receiving antibiotics, anti-fungal,anti-viral therapy;

4. Viral hepatitis,alcoholic or non-alcoholic liver disease,Wilson's disease or other inherited metabolic liver diseases.

5. Pregnancy or desire of pregnancy;

6. Breast-feeding;

7. Liver cancer or other malignant tumor;